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GMP Vs cGMP


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#1 YongYM

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Posted 23 June 2007 - 01:04 AM

Dear all:

May I know what is the difference between GMP and cGMP?

The pharmaceutical industries are required to be GMP certified. So, are they actually implementing GMP or cGMP? How about the food industries, implementing GMP or cGMP?

The codex standard CAC/RCP 1-1969 is GMP or cGMP?

Eagerly waiting for yours advices. TQ!


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#2 Charles.C

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Posted 23 June 2007 - 05:38 AM

Dear Yong YM,

GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago, may be less than adequate by today's standards.



http://www.gmp1st.com/gmp.htm (link was down but available via cached google using the URL at left)

(added - can also try this one - http://www.peri.org/...t_and_Good.html )

Seems to me that “c” is particularly popular for the US, it is officially included in some names of parts of 21 Code of Federal Regulations, eg Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

The basic concept of GMP / cGMP is claimed to be explained here -
http://en.wikipedia....turing_practice

Looks like everybody/everywhere has their own GMP and GxP. Just like ©hocolate :smile:

Rgds / Charles.C

added - The USFDA also seem to have a deeper interpretation of "GMP", at least in the pharmaceutical industry, see -

http://www.gmpcompli...GMP_Defined.htm
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#3 YongYM

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Posted 25 June 2007 - 06:50 AM

TQ Charles.


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#4 hacked

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Posted 02 July 2007 - 10:57 AM

Sir Charles is correct having mentioned cGMP means updated GMP standards or "current". We also have a notion here that cGMP includes Good Laboratory Practices and Good Warehousing Practices.


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